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Design Matters? Evaluating Implant Macro-Geometry in Immediate Implants: A Randomized Clinical Trial With Six-Month
Paolo Carosi1, Andrea Laureti2,3, Abdusalam Alrmali3,4
1CL Dentistry, Segni, Italy.
Objectives:
To compare the early stability trajectories of two tissue-level implant macro-designs after immediate placement, using monthly resonance frequency analysis (ISQ) over 6 months.
Materials And Methods:
Single-center randomized clinical trial in adults requiring immediate implant placement in posterior sites. ISQ was recorded at implant placement and monthly for 6 months. A linear mixed-effects model (subject-level random intercept; fixed effects for group, visit, their interaction, and baseline ISQ) was fitted, with the group × visit interaction as the primary inferential term. The 6-month endpoint was assessed by baseline-adjusted ANCOVA, with equivalence tested against a ±3 ISQ margin (2 one-sided tests).
Results:
Thirty implants were placed in 30 patients (aggressive self-tapping, n = 15; conservative uniform-thread, n = 15). ISQ increased significantly over time in both groups (p < 0.001). The group × visit interaction was significant (χ2 = 43.25, df = 5, p < 0.001); baseline-adjusted differences favored the aggressive design at t1 (+3.84 ISQ, 95% CI 1.64 to 6.03; p = 0.004) and t2 (+3.70, 95% CI 1.51 to 5.90; p = 0.005), and were no longer detectable from t3. At 6 months, the baseline-adjusted difference was -0.73 ISQ (95% CI -2.91 to 1.46; p = 0.500), and equivalence within ±3 ISQ was supported (TOST p = 0.021). All aggressive-design implants reached ISQ ≥ 70 by 3 months versus 33% in the conservative group (p = 0.001).
Conclusions:
Within the limitations of this trial, the more aggressive macro-design showed significantly higher stability during the first 2 months of healing, with significantly different trajectories over time, whereas at 6 months, no between-group difference was demonstrated and equivalence within the pre-specified ±3 ISQ margin was supported. Macro-design therefore influenced the timing of stability acquisition rather than stability at 6 months, supporting its relevance for early loading protocols.
Trial Registration:
ClinicalTrials.gov identifier: NCT06711744; Date of registration: 21 November 2024; EC Protocol ID: 6271 (Ethics Committee Lazio 3).